NCT01314937

Improving Early Childhood Growth and Development in Resource-poor LMICs by Incorporating Deworming in Integrated Child Health Care

Completed Phase 4 Last updated 25 August 2014

What this trial tests

Phase 4 trial testing Mebendazole in Malnutrition in 1,760 participants. Completed in 1 July 2013.

Timeline

1 September 2011

Primary endpoint
1 July 2013

1 July 2013

Quick facts

Lead sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,760
Start date	1 September 2011
Primary completion	1 July 2013
Estimated completion	1 July 2013
Sites	1 location across Peru

Drugs / interventions tested

• Mebendazole (MEBENDAZOLE) — full drug profile →
• Usual care

Conditions studied

• Malnutrition — all drugs for Malnutrition →
• Intestinal Diseases, Parasitic — all drugs for Intestinal Diseases, Parasitic →

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Who can join

Adults 12 Months to 24 Months, any sex, with Malnutrition or Intestinal Diseases, Parasitic. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Mean (± standard deviation) weight gain (kg)
  Time frame: from 12 to 24 months of age
  Weight will be measured at baseline (12 months of age), and follow-up (18 and 24 months of age) to assess the effect of the deworming intervention on growth (in terms of weight)

Sponsor's own description

Worldwide, over 2 billion people suffer from worm infections in developing countries. These infections are especially damaging to the health of children, resulting in both short-term and lifelong disability. Older children with worm infections are more likely to be stunted, underweight, vulnerable to other illnesses and perform poorly in school compared to non-infected children. Large-scale deworming programs in school-age children are therefore recommended by the World Health Organization (WHO). WHO also recommends deworming of preschool-age children (as of 12 months of age) in these areas; however, the benefits of deworming, especially in the 12-24 month age group, have been inadequately studied. This knowledge is urgently needed as studies show that all children have a similar potential for healthy growth and development, provided that appropriate nutrition and health interventions are given in the critical window of opportunity before the age of two.

Therefore, the investigators are proposing to undertake a randomized controlled trial to determine the effect of deworming program for improving growth and development in children between 12 and 24 months of age. Our results will provide solid rigorous evidence on if, when, and how often, deworming should be integrated into routine child health care packages provided by Ministries of Health in the 130 countries in the world where worm infections are endemic.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effect of Deworming on Growth in One-Year-Old Children Living in a Soil-Transmitted Helminth-Endemic Area of Peru: A Randomized Controlled Trial.
   Joseph SA, Casapía M, Montresor A, Rahme E, et al · · 2015 · cited 27× · PMID 26426270 · DOI 10.1371/journal.pntd.0004020
2. Risk factors associated with malnutrition in one-year-old children living in the Peruvian Amazon.
   Joseph SA, Casapía M, Blouin B, Maheu-Giroux M, et al · · 2014 · cited 24× · PMID 25503381 · DOI 10.1371/journal.pntd.0003369
3. The effect of deworming on early childhood development in Peru: A randomized controlled trial.
   Joseph SA, Casapía M, Lazarte F, Rahme E, et al · · 2015 · cited 6× · PMID 29349119 · DOI 10.1016/j.ssmph.2015.10.001
4. Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12-24 Months of Age.
   Joseph SA, Montresor A, Casapía M, Pezo L, et al · · 2016 · cited 6× · PMID 27139441 · DOI 10.4269/ajtmh.15-0816